FDA Label for Decongestant Pe Non Drowsy
View Indications, Usage & Precautions
Decongestant Pe Non Drowsy Product Label
The following document was submitted to the FDA by the labeler of this product Allegiant Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Phenylephrine HCl 5mg
Purpose
Nasal decongestant
Use(S)
- temporarily relieves sinus congestion and
pressure - temporarily relieves nasal congestion due to the
common cold, hay fever or other upper respiratory
allergies
Warnings
you are now taking a prescription monoamine
oxidase inhibitor (MAOI) (certain drugs for
depression, psychiatric or emotional conditions, or
Parkinson's disease), or for 2 weeks after stopping the
MAOI drug. If you do not know if your prescription drug
contains an MAOI, ask a doctor or pharmacist before
taking this product.
Ask A Doctor Before Use If
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
When Using This Product
do not exceed recommended dose
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
Pregnancy/Breastfeeding
ask a health professional before use
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Adults and children 12 years and over: 1 tablet every 4 hours
- do not take more than 6 tablets in 24 hours
Children under 12 years ask a doctor
Other Information
- do not use if imprinted safety seal under cap is broken or missing
Storage
- store at room temperature 20°– 25°C (68°– 77°F)
Inactive Ingredients
croscarmellose sodium, lactose, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake,
hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, titanium dioxide.
May contain propylene glycol
Questions
Call 1-888-952-0050 Monday through Friday
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